A Phase IA/II Multicenter, Dose-escalation Study of Oral AMN107 on a Continuous Daily Dosing Schedule in Adult Patients With Imatinib-resistant/Intolerant CML in Chronic or Accelerated Phase or Blast Crisis, Relapsed/Refractory Ph+ ALL, and Other Hematologic Malignancies.
Interventional
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• To determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of AMN107 as a single agent when administered as an oral once-daily and twice daily dose to adult patients with imatinib-resistant CML (phase l)
study duration
Yes
Novartis Pharmaceuticlas
Study Director
Novartis Pharmaceuticals
United States: Food and Drug Administration
CAMN107A2101
NCT00109707
May 2004
September 2012
Name | Location |
---|---|
Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
Stanford University Medical Center | Stanford, California 94305-5408 |
Swedish Cancer Institute | Seattle, Washington 98104 |
University of Rochester Medical Center | Rochester, New York 14642 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
Ochsner Clinic Foundation | New Orleans, Louisiana 70121 |
City of Hope National Medical Center | Los Angeles, California 91010 |
University of Colorado | Denver, Colorado 80217 |
Duke University Medical Center | Durham, North Carolina 27710 |
Oregon Health Sciences University | Portland, Oregon |
Wayne State University | Detroit, Michigan 48202 |
Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
The Jones Clinic | Germantown, Tennessee 38138 |
Wake Forest University Baptist Medical Center | Winston-Salem, North Carolina 27157 |
H. Lee Moffitt Cancer Center/University of South Florida Dept.of H. Lee Moffitt | Tampa, Florida 33612 |
University of Chicago Medical Center Dept. of U. of Chicago Hosp(3) | Chicago, Illinois 60546 |
University of Illinois at Chicago Divisionof Hematology/Oncology | Chicago, Illinois |
Indiana Blood and Marrow Institute Dept of Indiana Blood&Mar (2) | Beach Grove, Indiana 46107 |
Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins Med. Div.of Hematologic Malignancie | Baltimore, Maryland 21231 |
University of Michigan Health System Clinical Trials Office | Ann Arbor, Michigan 48109 |
Mayo Clinic - Rochester | Rochester, Minnesota 55905 |
Roswell Park Cancer Institute Rosewell SC | Buffalo, New York 14263 |
Vanderbilt University Medical Center, Clinical Trials Center Investigational Drug Services | Nashville, Tennessee 37212 |
MD Anderson Cancer Center/University of Texas | Houston, Texas 77030 |